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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screwdriver
510(k) Number K862689
Device Name 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact FREDERICK W DAWSON
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact FREDERICK W DAWSON
Regulation Number888.4540
Classification Product Code
HXX  
Date Received07/15/1986
Decision Date 09/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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